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PMA-Zeolite-Clinoptilolite Effects in Crohn Disease

NCT04370535 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-05-20

No results posted yet for this study

Summary

This pilot study aims to evaluate the safety and efficacy of PMA-zeolite when used in patients with uncontrolled CD (Crohn´s disease). The effect of the PMA-zeolite will be compared between a control-group (healthy volunteers) receiving either PMA-zeolite or placebo and the test-group (suffering from uncontrolled CD) and receiving either PMA-zeolite or placebo. In addition, this pilot-study should furthermore provide indications for the effect-size in order to estimate an effect for an eventual further human trial.

Conditions

  • Crohn Disease

Interventions

DEVICE

cellulose

The subjects of group A and group C receive boxes containing placebo for supplementation for a total of 12 weeks.

DEVICE

PMA-zeolite

The subjects of group B and group D receive boxes containing PMA-zeolite for supplementation for a total of 12 weeks.

Sponsors & Collaborators

  • University of Rijeka

    collaborator OTHER

  • Ciim Plus, d.o.o.

    lead INDUSTRY

Principal Investigators

  • Krešimir Pavelić, PhD, M.D. · Juraj Dobrila University of Pula

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-17
Primary Completion
2019-11-28
Completion
2020-05-15

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04370535 on ClinicalTrials.gov